ID

31572

Description

Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers; ODM derived from: https://clinicaltrials.gov/show/NCT00676286

Lien

https://clinicaltrials.gov/show/NCT00676286

Mots-clés

Versions (1)
  1. 06/09/2018 06/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

6 septembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00676286

Anglais

Eligibility Prostate Cancer NCT00676286

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
registration must occur within 16 weeks of last biopsy
Description

Biopsy Recently

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0332185
history and physical exam (including dre) within 8 weeks prior to registration
Description

Medical History Recently | Physical Examination Recently | Digital Rectal Examination Recently

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1384593
UMLS CUI [3,2]
C0332185
patients must have indolent prostate cancer including all of the following: low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
Description

Prostate carcinoma indolent | Prostate carcinoma Low Risk | Involvement with Disease Core biopsy Percentage | Involvement with Disease Biopsy Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0234227
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C3538919
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1318309
UMLS CUI [3,4]
C0439165
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0005558
UMLS CUI [4,4]
C1265611
patients must have a minimum of six biopsies (sextant) at registration
Description

Sextant biopsy Quantity Minimum

Type de données

boolean

Alias
UMLS CUI [1,1]
C3846092
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1524031
psa test within 8 weeks registration
Description

Prostate specific antigen measurement Recently

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0332185
creatinine level below 100 umol/l within 8 weeks of registration
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
patients must have no contraindications to mri scans
Description

Medical contraindication Absent MRI scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024485
no history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
Description

Malignant Neoplasms Previous Absent | Exception Skin carcinoma | Exception Cancer Other Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1707251
UMLS CUI [3,3]
C0023671
patients must be reliable for follow up
Description

Patients Available Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient does not have histologically-proven adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0332197
last biopsy greater than 16 weeks prior to registration
Description

Biopsy Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0205156
history and physical exam (including dre) greater that 8 weeks prior to registration
Description

Medical History Previous | Physical Examination Previous | Digital Rectal Examination Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1384593
UMLS CUI [3,2]
C0205156
patient does not have indolent disease
Description

Disease indolent Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0234227
UMLS CUI [1,3]
C0332197
patient has less than six sextant biopsies at registration
Description

Sextant biopsy Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C3846092
UMLS CUI [1,2]
C1265611
psa test done greater than 8 weeks from registration
Description

Prostate specific antigen measurement Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0205156
creatinine level greater than 100 umol/l within 8 weeks of registration
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
contraindications to mri scans
Description

Medical contraindication MRI scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
history of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
Description

Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Cancer Other Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1707251
UMLS CUI [3,3]
C0023671
patients that are not reliable for follow up
Description

Patients Unreliable Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C4061925
UMLS CUI [1,3]
C3274571
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Similar models

Eligibility Prostate Cancer NCT00676286

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically proven adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Biopsy Recently
Item
registration must occur within 16 weeks of last biopsy
boolean
C0005558 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Medical History Recently | Physical Examination Recently | Digital Rectal Examination Recently
Item
history and physical exam (including dre) within 8 weeks prior to registration
boolean
C0262926 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1384593 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Prostate carcinoma indolent | Prostate carcinoma Low Risk | Involvement with Disease Core biopsy Percentage | Involvement with Disease Biopsy Quantity
Item
patients must have indolent prostate cancer including all of the following: low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
boolean
C0600139 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
C1314939 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Sextant biopsy Quantity Minimum
Item
patients must have a minimum of six biopsies (sextant) at registration
boolean
C3846092 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Prostate specific antigen measurement Recently
Item
psa test within 8 weeks registration
boolean
C0201544 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
creatinine level below 100 umol/l within 8 weeks of registration
boolean
C0201976 (UMLS CUI [1])
Medical contraindication Absent MRI scan
Item
patients must have no contraindications to mri scans
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Malignant Neoplasms Previous Absent | Exception Skin carcinoma | Exception Cancer Other Life Expectancy
Item
no history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
Patients Available Follow-up
Item
patients must be reliable for follow up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Adenocarcinoma of prostate Absent
Item
patient does not have histologically-proven adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Biopsy Previous
Item
last biopsy greater than 16 weeks prior to registration
boolean
C0005558 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical History Previous | Physical Examination Previous | Digital Rectal Examination Previous
Item
history and physical exam (including dre) greater that 8 weeks prior to registration
boolean
C0262926 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1384593 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Disease indolent Absent
Item
patient does not have indolent disease
boolean
C0012634 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Sextant biopsy Quantity
Item
patient has less than six sextant biopsies at registration
boolean
C3846092 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prostate specific antigen measurement Previous
Item
psa test done greater than 8 weeks from registration
boolean
C0201544 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
creatinine level greater than 100 umol/l within 8 weeks of registration
boolean
C0201976 (UMLS CUI [1])
Medical contraindication MRI scan
Item
contraindications to mri scans
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Cancer Other Life Expectancy
Item
history of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
Patients Unreliable Follow-up
Item
patients that are not reliable for follow up
boolean
C0030705 (UMLS CUI [1,1])
C4061925 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
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